Hi, I’m
JANAKIRAM KATINENI
Bangalore
Summary
Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success.
Overview
12
years of professional experience
6
years of post-secondary education
5
Certifications
1
Language
Work History
Eli Lilly and CompanyIndia
Manager - Global Pharmacovigilance
12.2017 - Current
Job overview
- Case Management, including Research study and Literature cases
- Trained and mentored around 150 people across different functions globally
- SME for the team and coordinate with QPPV, LSO's and other stake holders to align with the process
- Innovated Case Processing Assistance Tool (using VBA Macros)
- Supported Bayer integration and established Reconciliation process
- Executed and tested PV Entry 1.4 upgrade Manually and SSO login
- Identified challenges and provided pragmatic solutions
- Hands on experience on Argus, Jira and Veeva Vault, Handling deviations in Veeva QMS
- Support, draft and review of SOP's, WI's and other guidance in alignment with changing global regulations
- Quality management: In process quality review (IPQR) tool developed to comply with global regulatory requirements
- Case question log (CQL) support global queries
- Supports in internal audits and authority inspections
- Global GPV Support
- Refresher Trainings to PV teams
- Submission of case reports (electronic and manually)
- Testing of PVEntry, PVExpress applications with different criteria
- Validation rule setting for PV Database based on regulatory obligations
- Good Exposure on Regulatory requirements of Computerized systems and sound knowledge of US FDA 21 CFR Part 11 and GVP, GAMP5, ICH Quality and Efficacy guidelines
- Involved in strategic planning for the future scope of progress and development in the field of Pharmacovigilance
- Part of Company's core team for business and Vendor communication
- Quality review of adverse event reports and ad-hoc activities such as training team, assigning work, conduct quality huddles etc.
Mylan LaboratoriesBangalore
Senior Executive-PSRM
12.2015 - 11.2017
Job overview
- Case processing and Quality review of adverse events
- Reconciliation by generating line listings- compliance with pharmacovigilance agreements
- Collaboration with LSO and partners for ICSR's data exchange
- Reconciliation between Mylan and business partners and Affiliates (APAC, AMERS and European Union)
- MHRA Audit preparation and support
- Vendor Quality Review and Training
- Medical literature monitoring (MLM) cases and Reaction Pharmacovigilance Services (RPS) case processing and review
- Check listedness of events as per company core data sheet (CCDS), summary of product characteristics (SmPC) and investigational brochure (IB)
- Validation and triage.
AccentureBangalore
Medical Service Analyst - PV
09.2012 - 11.2015
Job overview
- Serious case processing PV: Serious ICSR'S, Non-Interventional studies, Literature, Market Research, Named Registries, Pregnancy Cases, and ICT (interventional clinical trial), SUSAR's, DLT and pre-treatment cases
- Create cases in global safety database based on regulatory and service level agreements
- Perform duplicate checks, Triage, Acknowledge, Archive all source documents
- Identifying and processing of cases with adverse event of special interest (AESI) and important medical event (IME)
- Perform In-line Quality checks on serious cases and non-serious AESI cases entered in Global Safety Database guidelines, applicable service level agreement (SLA) and regulatory day
- Track and review the individual and team scores for tracking trends and identify any immediate action to be taken
- Subject matter expert (SME) to the team
- Ensure overall deal compliance to Accenture and Client process, and support internal, client audits and Regulatory requirements.
Datamonitor (Cognizant)Hyderabad
Researcher - Market Research
09.2011 - 01.2011
Job overview
- Collect information on pharmaceutical pipelines, sales, epidemiology, patents and more, to give a comprehensive view of the biopharmaceutical business landscape
- Extraction of the relevant information from the clinical trials, pipeline drugs through reports received from different sources
- Analyze the data, update product information including mechanism of action in tool (Medtrack Database) and develop study reports, write narratives relevant to the therapeutic area.
Education
Jawaharlal Nehru Technological UniversityAnantapur, Andhra Pradesh
M. Pharm
01.2009 - 01.2011
University Overview
Score: 77.1%
Jawaharlal Nehru Technological UniversityHyderabad, India
B. Pharm
01.2005 - 01.2009
University Overview
Score: 67.5%
Skills
ICSR's Quality review, Reconciliation, Literature Review, Clinical trial case processing-SUSAR's, Regulatory Submissions (electronic and manual)US FDA 21 CFR Part 11, GVP, ICH Quality and Efficacy guidelines E2AF & UAT TestingDrafting SOP's & WI's and GuidanceAudit preparation & SupportMS Word, Excel, Power point, VBA MacrosTools & Databases: Empirica Trace, Argus, PVWork(s) Vet, PVEntry, WHO DD, PVExpress, MeDDRA, VeDDRA coding, Veeva VaultNarrative writingLiterature ReviewWHO-DD codingMeDDRA coding (260)Clinical trial case processing-SUSAR'sCreating advance conditions-ArgusHandling Imported casesReports Submission (electronic and manual)
Certification
Registered Pharmacist (License Number: 62236/A1)
Accomplishments
- Innovated case processing assistance tool (implemented process simplification)
- Supported in developing PV database.
- Formulated Training Plan- Trained & mentored around 150 associates.
- Manually tested PV Entry 1.4 upgrade
- Bayer AG audit & EMEA audit
- Cloud 9 collaborator Award-Q32021, Q1&Q32022, Global Awards, Good Samaritan Awards, Shining star award-2023
- Holding B1/B2 USA visa- for 8 years
Honors Promotions
- Promotion, Sr. Associate Manager, Manager, Elanco, IAC, 2022
- Promotion, Associate Manager, Sr. Associate Manager, Elanco, IAC, 2020
- Promotion, Medical Service Analyst, Quality Reviewer, Accenture, 2014
Areas Of Interest
- Subject Matter Expert
- Project Management
Pronouns
He/Him/His
Personal Information
- Date of Birth: 07/12/88
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Disclaimer
I do hereby declare that the particulars of information and facts stated herein above are true and complete to the best of my knowledge.
Timeline
Manager - Global Pharmacovigilance
Eli Lilly and Company
12.2017 - Current
Senior Executive-PSRM
Mylan Laboratories
12.2015 - 11.2017
Medical Service Analyst - PV
Accenture
09.2012 - 11.2015
Researcher - Market Research
Datamonitor (Cognizant)
09.2011 - 01.2011
Jawaharlal Nehru Technological University
M. Pharm
01.2009 - 01.2011
Jawaharlal Nehru Technological University
B. Pharm
01.2005 - 01.2009